Pacemaker Timing Adjustment Tested for High Blood Pressure
Tests a pacemaker timing setting in adults with high blood pressure.
Plain-language title generated from the registry record
Registry title: BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
Key facts
- Where
- Katowice, Krakow, Lodz, Lublin, Poznan, Szczecin, Warsaw, Wroclaw, and Zabrze, PolandSee the 9 sites
Where in Poland
- Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W KatowicachKatowice, PolandTaking people
- Jagiellonian University HospitalKrakow, PolandTaking people
- Centralny Szpital Kliniczny Uniwersytetu Medycznego w ŁodziLodz, PolandTaking people
- Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała WyszyńskiegoLublin, PolandTaking people
- Uniwersytecki Szpital Kliniczny w PoznaniuPoznan, PolandTaking people
- Uniwersytecki Szpital Kliniczny nr 2 PUMSzczecin, PolandTaking people
- Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu MedycznegoWarsaw, PolandTaking people
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we WrocławiuWroclaw, PolandTaking people
- Silesian Center for Heart DiseasesZabrze, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Orchestra BioMed, Inc
- Trial code
- NCT06059638
- Record updated
- 2 October 2026
- Original description
A prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a dual-chamber Medtronic Astra/Azure pacemaker.Read full original descriptionShow less
BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
A prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a dual-chamber Medtronic Astra/Azure pacemaker.
Inclusion: Patient has or is indicated for a dual-chamber pacemaker. Visit 1 can be performed within 30 days prior to a planned implant of a Medtronic Astra/Azure dual-chamber pacemaker system or at any time thereafter; On a stable antihypertension treatment regimen with at least 1 class of antihypertensive drug; Office SBP ≥135 mmHg and <180 mmHg; Average 24-Hour aSBP ≥130 mmHg and <170 mmHg.
Exclusion: Prior percutaneous or surgical coronary, carotid, or endovascular intervention within 3 months; Has an active or prior device-based anti-hypertensive treatment (e.g., renal denervation procedure, baroreflex activation therapy); History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months; Myocardial infarction (MI) within 3 months; Has an existing active cardiac device or neurostimulator other than the recent Astra/Azure pacemaker implant; LVEF <50%; NYHA Class III-IV; Permanent atrial fibrillation; Mitral valve regurgitation greater than or equal to grade 3; Aortic stenosis with a valve area less than 1.5 cm2.